Acetaminophen

Description

Children's Acetaminophen Liquid is formulated as a pain reliever and fever reducer, containing 160 mg of acetaminophen per 5 mL. This product is sugar-free, alcohol-free, and aspirin-free, making it suitable for pediatric use. It is available in a cherry flavor and is packaged in a 4 fl. oz. (118 mL) bottle. The National Drug Code (NDC) for this formulation is 69367-323-04, and it is manufactured by Westminster Pharmaceuticals.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to utilize only the enclosed dosing cup specifically designed for this product to ensure accurate dosing. When determining the appropriate dose, weight should be the primary consideration; however, age may be used as an alternative if weight is not available.

The dosing regimen allows for the administration of the medication every 4 hours as needed, while symptoms persist, with a maximum of five doses per day or as directed by a physician.

Dosage by Weight and Age:

• For patients weighing under 24 lbs. (under 2 years), consultation with a physician is required prior to administration.

• For patients weighing 24 to 35 lbs. (2 to under 4 years), the recommended dose is 5 mL (1 teaspoon).

• For patients weighing 36 to 47 lbs. (4 to under 6 years), the recommended dose is 7.5 mL (1 1/2 teaspoons).

• For patients weighing 48 to 59 lbs. (6 to under 9 years), the recommended dose is 10 mL (2 teaspoons).

• For patients weighing 60 to 71 lbs. (9 to under 11 years), the recommended dose is 12.5 mL (2 1/2 teaspoons).

• For patients weighing 72 to 95 lbs. (11 to under 12 years), the recommended dose is 15 mL (3 teaspoons).

It is essential to follow these guidelines closely to ensure safe and effective use of the medication.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the potential for acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a prompt consultation with a physician is recommended.

This product should not be used in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to consult a doctor or pharmacist.

Prior to administration, healthcare professionals should inquire about the patient's medical history, particularly if the child has liver disease. Additionally, consultation with a doctor or pharmacist is recommended if the child is currently taking the anticoagulant warfarin.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, redness or swelling is observed, or any new symptoms develop. These may indicate a serious underlying condition.

In cases of overdose, immediate medical attention is crucial. Patients or caregivers should be advised to contact a Poison Control Center or seek emergency medical help without delay, even if no signs or symptoms are apparent, as prompt intervention is essential for both adults and children.

Side Effects

Severe liver damage may occur in patients if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount, or if the medication is used concurrently with other drugs containing acetaminophen. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

It is advised that patients stop use and consult a doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, or if any new symptoms appear, as these may indicate a serious condition.

Patients with a history of liver disease should seek medical advice before using this medication. Additionally, consultation with a doctor or pharmacist is recommended for patients taking the blood-thinning medication warfarin.

Parents and caregivers should ensure that the medication is kept out of reach of children. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to administration if the child is concurrently taking warfarin, a blood-thinning agent. This is essential to ensure appropriate monitoring and to mitigate the risk of potential interactions that may affect coagulation parameters.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age (weighing less than 24 lbs) should be evaluated by a healthcare professional before use. Dosage recommendations for pediatric patients are based on weight and age as follows:

• For children weighing 24 to 35 lbs (2 to under 4 years): 5 mL (1 tsp)

• For children weighing 36 to 47 lbs (4 to under 6 years): 7.5 mL (1 1/2 tsp)

• For children weighing 48 to 59 lbs (6 to under 9 years): 10 mL (2 tsp)

• For children weighing 60 to 71 lbs (9 to under 11 years): 12.5 mL (2 1/2 tsp)

• For children weighing 72 to 95 lbs (11 to under 12 years): 15 mL (3 tsp)

The maximum daily amount should not exceed 5 doses within a 24-hour period. Caution is advised regarding liver health; severe liver damage may occur if the recommended dosage is exceeded or if the medication is taken concurrently with other products containing acetaminophen. Consultation with a healthcare professional is recommended for children with liver disease or those taking the anticoagulant warfarin. Parents and caregivers should discontinue use and seek medical advice if pain persists for more than 5 days, fever lasts more than 3 days, or if any new symptoms arise.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use in this population. Given the lack of detailed information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are appropriately assessed.

Lactation

There are no specific warnings or recommendations regarding the use of acetaminophen in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided information. Therefore, healthcare professionals may consider the use of acetaminophen in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of potential risks associated with the compound in these areas.

Postmarketing Experience

Severe skin reactions have been reported in postmarketing experience with acetaminophen. Symptoms associated with these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Healthcare professionals and patients are encouraged to report any side effects to Westminster at 1-844-221-7294, available Monday through Friday from 9 a.m. to 5 p.m. EST, or to the FDA at 1-800-FDA-1088.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: pain worsens or persists for more than 5 days; fever worsens or lasts more than 3 days; redness or swelling is observed; or if any new symptoms arise, as these may indicate a serious condition.

Additionally, it is important for healthcare providers to recommend that patients consult a doctor before using this medication if their child has liver disease. Patients should also be advised to speak with a doctor or pharmacist before use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

Dispensed product should be provided in a tight, light-resistant container equipped with a child-resistant cap.

Storage conditions require maintaining a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). Proper adherence to these storage guidelines is essential to ensure product integrity and safety.

Additional Clinical Information

The medication is administered orally, with the recommended dosing allowing for repetition every 4 hours as needed, up to a maximum of five times per day, or as directed by a healthcare professional. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Acetaminophen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)